Brand Name(s):

Prograf®

Other Name(s):

FK 506

IMPORTANT WARNING

Tacrolimus should only be given under the supervision of a doctor who is experienced in treating people who have had an organ transplant and in prescribing medications that decrease the activity of the immune system.

Tacrolimus decreases the activity of your immune system. This may increase the risk that you will get a serious infection. If you experience any of the following symptoms, call your doctor immediately: sore throat; cough; fever; extreme tiredness; flu-like symptoms; warm, red, or painful skin; or other signs of infection.

When your immune system is not working normally, there may be a greater risk that you will develop cancer, especially lymphoma (a type of cancer that begins in the cells of the immune system). The longer you take tacrolimus or other medications that decrease the activity of the immune system, and the higher your doses of these medications, the more this risk may increase. If you experience any of the following symptoms of lymphoma, call your doctor immediately: swollen lymph nodes in the neck, armpits, or groin; weight loss; fever; night sweats; excessive tiredness or weakness; cough; trouble breathing; chest pain; or pain, swelling, or fullness in the stomach area.

Talk to your doctor about the risks of taking tacrolimus.

WHY is this medicine prescribed?

Tacrolimus is used along with other medications to prevent rejection (attack of a transplanted organ by the immune system of a person receiving the organ) in people who have received kidney, liver, or heart transplants. Tacrolimus is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.

HOW should this medicine be used?

Tacrolimus comes as a capsule to take by mouth. It is usually taken twice a day. Space your doses 12 hours apart, and take tacrolimus at the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tacrolimus exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will monitor you carefully and adjust your dose as needed. Talk to your doctor often about how you are feeling during your treatment. Ask your doctor if you have any questions about how much tacrolimus you should take.

Tacrolimus can only prevent rejection of your transplant as long as you are taking the medication. Continue to take tacrolimus even if you feel well. Do not stop taking tacrolimus without talking to your doctor.

Are there OTHER USES for this medicine?

Tacrolimus is also sometimes used to treat fistulizing Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, fever, and the formation of abnormal tunnels connecting the digestive tract to other organs or the skin). Talk to your doctor about the risks of using this medication to treat your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking tacrolimus,

tell your doctor and pharmacist if you are allergic to tacrolimus or any other medications.

tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amphotericin B (Abelcet, Ambisome, Amphotec); antacids; certain antibiotics including aminoglycosides such as amikacin, gentamicin, neomycin (Neo-Fradin), streptomycin, and tobramycin (Tobi), and macrolides such as clarithromycin (Biaxin), erythromycin (EES, E-Mycin, Erythrocin), and troleandomycin (TAO) (not available in the US); antifungal medications such as clotrimazole (Lotrimin, Mycelex), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral) and voriconazole (Vfend); bromocriptine (Parlodel); calcium channel blockers such as diltiazem (Cardizem), nicardipine (Cardene), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin); caspofungin (Cancidas); chloramphenicol; cimetidine (Tagamet); cisapride (Propulsid) (not available in the U.S.); cisplatin (Platinol); danazol (Danocrine); certain diuretics ('water pills'); ganciclovir (Cytovene); hormonal contraceptives (birth control pills, patches, rings, inserts, or injections); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir); lansoprazole (Prevacid); certain medications for seizures such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); methylprednisolone (Medrol); metoclopramide (Reglan); nefazodone; omeprazole (Prilosec); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); and sirolimus (Rapamune). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects. Many other medications may also interact with tacrolimus, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

tell your doctor if you are taking or have recently stopped taking cyclosporine (Gengraf, Neoral, Sandimmune). If you were taking cyclosporine, your doctor will probably tell you not to start taking tacrolimus until 24 hours after you took your last dose of cyclosporine. If you stop taking tacrolimus, your doctor will also tell you to wait 24 hours before starting to take cyclosporine.

tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort.

tell your doctor if you have or have ever had heart, kidney, or liver disease.

tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tacrolimus, call your doctor.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tacrolimus.

you should know that taking tacrolimus may increase the risk that you will develop skin cancer. Protect yourself from skin cancer by avoiding unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds) and wearing protective clothing, sunglasses, and sunscreen with a high skin protection factor (SPF).

you should know that tacrolimus may cause high blood pressure. Your doctor will monitor your blood pressure carefully, and may prescribe medication to treat high blood pressure if it develops.

you should know that there is a risk that you will develop diabetes during your treatment with tacrolimus. African American and Hispanic patients who have had kidney transplants have an especially high risk of developing diabetes during their treatment with tacrolimus. Tell your doctor if you or anyone in your family has or has ever had diabetes. If you experience any of the following symptoms, call your doctor immediately: excessive thirst; excessive hunger; frequent urination; blurred vision or confusion.

do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Tacrolimus may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

headache

uncontrollable shaking of a part of the body

diarrhea

constipation

nausea

vomiting

heartburn

stomach pain

loss of appetite

difficulty falling asleep or staying asleep

dizziness

weakness

back or joint pain

burning, numbness, pain, or tingling in the hands or feet

rash

itching

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

decreased urination

pain or burning on urination

swelling of the arms, hands, feet, ankles, or lower legs

weight gain

unusual bleeding or bruising

seizures

coma (loss of consciousness for a period of time)

Tacrolimus may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at

] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

hives

sleepiness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to tacrolimus.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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This content is reviewed regularly and is updated when new and relevant evidence is made available. This information is neither intended nor implied to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with questions regarding a medical condition.